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Menopause and Hormone Replacement Therapy

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					Menopause and Hormone Replacement Therapy
Sandra E. Brooks, MD, FACS, FACOG Associate Professor
Director, Div GYN Oncology Dept. Obstetrics and Gynecology University of Maryland School of Medicine

What is Menopause?
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During the perimenopausal period (up to 10 years before menopause), the ovaries decrease production of the "female hormones" estrogen and progesterone, the hormones which allow a woman to become pregnant and to menstruate. Hormones also affect many other functions in a woman’s body such as the circulatory system, urogenitary system, nervous system, skeletal system, memory, sexuality, skin, vision, and teeth. The average age for menopause in American women is 51 Because most women will live a third of their life after menopause, it is important to be aware of the symptoms, systemic effects, and available treatment options associated with estrogen loss.

Acute Effects of Menopause
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Reproductive Tract:  Symptoms: cessation of menses, hot flashes, decreased vaginal lubrication  Signs: vaginal epithelial atrophy, decreased size of uterus, cervix, or ovaries Urinary Tract:  Symptoms: urgency, frequency, nocturia  Signs: urothelial atrophy, hypertonic unstable bladder Breasts:  Symptoms: decreased tenderness  Signs: decreased size, fewer benign cysts

Late Effects of Menopause
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Osteoporosis  decreased trabecular bone density due to increased osteoclastic activity Cardiovascular Disease  the most common cause of death in women  rate of CVD increases steadily reaching parity with men by age 70  lipid profile changes:
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increased LDL decreased HDL

Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women (WHI)1- 1993-1998

Objective:
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To assess the major health benefits and risks of HRT in the U.S. based on a randomized controlled primary prevention trial

WHI Study 16,080 Women age 50-79 No prior hysterectomy
8506 Premarin 0.625 mg/d Provera 2.5mg/d

7574 Control Placebo

WHI Study HRT increased Risk of Heart Disease

Coronary
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Stroke

non-fatal MIs within 1 yr.
41% I

Heart Disease 29%

increase in stroke began within 2 years

207% PE 213%

DVT

Conclusions of Women’s Health Initiative Study
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HRT should not be initiated or continued for primary prevention of Heart Disease

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The risks of cardiovascular disease and breast cancer must be weighed against the benefits of fracture reduction and postmenopausal symptom relief.

Estrogen in the Prevention of Atherosclerosis Trial2- 2001
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Objective:
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To examine the effects of unopposed 17-b estradiol on atherosclerosis progression via a randomized, double-blind, placebo-controlled trial

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Methods:
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Study Population:  222 women aged 45 years and older  Experimental Group  unopposed 17-b estradiol (1 mg/d)  Control Group  placebo

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Conclusions of HERS  No overall benefit of hormone treatment  Unexpected pattern of increased risk during the first year of follow-up  7 other randomized clinical trials conclude:  HRT does not reduce risk of adverse event in women with heart disease

Response to WHI
 Important
 Women

to note:

with severe hot flashes were not enrolled in large numbers  WHI only applies to w omen 50-79 who are taking premarin/provera  Premarin only arm continues

Contraindications to HRT
• Pregnancy or Breastfeeding. • Liver disease • Undiagnosed vaginal bleeding. • History of certain cancers. • History of deep vein thromboses or other blood clotting disorders.

HRT relieves Hot Flashes, Vaginal Dryness and Insomnia but may have Side Effects
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Return of periods Irregular vaginal bleeding/spotting Headache Nausea Breast tenderness Bloating (progesterone) Weight gain (progesterone): generally only 2-3 pounds can be “blamed” on the hormones: the rest is decreased metabolism associated with menopause, increased caloric intake and/or decreased exercise. May exacerbate depression (progesterone) Enlargement of uterine fibroids Exacerbation of endometriosis Fluid retention (may exacerbate asthma, epilepsy, migraine, heart disease, kidney disease) Spotty darkening of the skin

Who should take HRT?
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Role of HRT for any indication other than symptomatic relief of severe hot flashes  Premature menopause  Alternatives
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Selective serotonin re uptake inhibitors for hot flashes SERMs or bisphosphonates for prevention of osteoporosis Statins for cholesterol Vaginal estrogen or rings, lubricants for vaginal dryness

Alternatives to HRT
PHYTOESTROGENS
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There are 3 main groups: isoflavones, lignans, and coumestans. Isoflavones are considered “weak” estrogen receptor modulators; they mimic the role of estrogen. However, they can mimic the good actions and the not so good- they can also function to block the action of estrogen at some sites It is still unclear whether these herbs are safe for women at risk for breast cancer or its recurrence. Recommended dose of 6.5 g of soy per serving for a total of 25 g per day. Medical facts about soy: Soy contains 3 isoflavones: Daidzin, genistin, and glysitin. In addition to its preventive benefits in cardiovascular disease, soy has been shown to reduce the frequency of hot flashes and to reduce the incidence of osteoporosis. Six studies have shown that soy isoflavones can reduce the frequency of hot flashes. To mimic the typical Japanese diet, women should get 60-90 mg of soy isoflavones per day. 1 cup of tofu = 75 mg= the same half cup of soybeans = 3 cups of soy milk.

Herbal Preparations
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Black cohosh: This is currently touted as the herbal preparation most likely to prevent hot flashes. Clinical studies have been done to show a reduction in the frequency and intensity of hot flashes, improvement in “global” menopausal symptoms, and in vaginal lubrication. It is probably the most well studied of the phytoestrogenic herbal preparations. Most of these studies were not nearly as well designed as most physicians would like,

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Red Clover: This herb contains four isoflavones, including genistein, the most active component of soy. The most popular dietary supplement derived from red clover is Promensil ™.
Clinical trials with Promensil did survey women to test their level of satisfaction; 93% of users said they wanted to continue taking it. A 500 mg Promensil tablet contains 40 mg of plant estrogens. This is the equivalent of one cup of soy milk and four cups of chickpeas.

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Herbal Preparations
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Ginkgo biloba: This herb is commonly used as a mood elevator or to improve memory and other cognitive functions. It has also been documented to cause bleeding problems in several individuals, with or without other medicines. Speak with your physician if you plan to take this herb, especially if you are taking medicines for bleeding or clotting problems or for arthritis. Wild yam: This has been touted as a natural source of “natural progesterone”. It contains diosgenin, which is not converted to active hormones in the body however, and it has been shown to have NO effects on estrogen or progesterone receptors. Vaginal Lubricants: There are numerous non-prescription vaginal lubricants on the market such as K-Y Jelly ™ and Vagisil ™. Never use a water insoluble preparation in the vagina, e.g. Vaseline ™.

References and Links
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Writing Group for the WHI Investigators 2002. Journal of American Medical Association July 17, 2002 288: 321-333 Menopausal Medicine Vol 11, 2003/ Kuller, Lewis H. 2002. Arteriosclerosis, Thrombosis and Vascular Biology January 1, 2003; 23(1): 11-16 Herrington, David, MD, MHS 2003. Hormone Replacement Therapy and Heart Disease: Replacing Dogma with Data. Circulation Jan 7, 2003; 107(1) :2-4. ACOG.org Cancer.org WCN.org


				
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